Using Pneumococcal Vaccines in Combination for Maximum Protection From Ear and Lung Infections in First 3 Years of Life (PREV-IX_B)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Menzies School of Health Research
ClinicalTrials.gov Identifier:
NCT01735084
First received: November 15, 2012
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

HYPOTHESES:

  1. That infants receiving PHiD-CV10 as a booster at 13 months of age, compared to controls having no PHiD-CV10 booster (i.e. standard PCV13), will have higher HiD antibody levels, lower carriage of NTHi, and less tympanic membrane perforation at 18 and 36 months of age.
  2. That infants receiving PCV13 as a booster at 13 months of age, compared to controls having no PCV13 (i.e. PHiD-CV10 booster) will have higher antibody levels to serotypes 3, 6A and 19A, less carriage of these serotypes, and less tympanic membrane perforation at 18 and 36 months of age.

Condition Intervention Phase
Otitis Media
Febrile Illness
Cough
Lower Respiratory Tract Infection
Upper Respiratory Tract Infection
Biological: Prevenar13
Biological: Synflorix
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pneumococcal Conjugate Vaccine (PCV) Schedules for the Northern Territory (NT): Randomised Controlled Trial of Booster Vaccines to Broaden and Strengthen Protection From Invasive and Mucosal Infections.

Resource links provided by NLM:


Further study details as provided by Menzies School of Health Research:

Primary Outcome Measures:
  • Immune response [ Time Frame: At 18 months of age ] [ Designated as safety issue: No ]
    The primary outcome will be the proportion of subjects with serotype-specific antibody above the level required for protection from IPD in each study group at 18 months of age, 5 months after the booster dose. This will be determined in ELISA assays.


Secondary Outcome Measures:
  • Nasopharyngeal carriage [ Time Frame: At 13, 18 and 36 months of age ] [ Designated as safety issue: No ]
    At baseline (13 mo), 18 and 36 months of age, the proportion of children with a any carriage of serotype 3, 6A and 19A pneumococci b any carriage of any NTHi

  • Otitis media [ Time Frame: At 13, 18 and 36 months of age ] [ Designated as safety issue: No ]
    At baseline (13 mo), 18 and 36 months of age, the proportion of children with c any otitis media. d any tympanic membrane perforation


Other Outcome Measures:
  • Episodes of respiratory illness and acute otitis media [ Time Frame: Between baseline (13 mo) and 36 months of age ] [ Designated as safety issue: No ]
    Between baseline (13 mo) and 36 months of age Episodes of respiratory illness and acute otitis media


Estimated Enrollment: 270
Study Start Date: December 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prevenar13
The booster dose of Prevenar13 is 0.5 mL given intramuscularly only, with care to avoid injection into or near nerves and blood vessels. The preferred sites are anterolateral aspect of the thigh (vastus lateralis muscle) in infants or the deltoid muscle of the upper arm in young children.
Biological: Prevenar13

The vaccine is a ready to use homogeneous white suspension for intramuscular injection, supplied as a pre-filled syringe.

Active ingredients

Each 0.5 mL dose contains:

2.2 μg of pneumococcal purified capsular polysaccharides for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F 4.4 μg of pneumococcal purified capsular polysaccharides for serotype 6B. Each serotype is individually conjugated to non-toxic diphtheria CRM197 protein and adsorbed on aluminium phosphate (0.565 mg).

Other Names:
  • PCV13
  • Prevnar13
Experimental: Synflorix
The booster vaccination schedule consists of one dose of 0.5 ml with an interval of at least 1 month between doses.
Biological: Synflorix
The 10-valent vaccine contains 1 µg of purified capsular polysaccharide of pneumococcal serotypes 1, 5, 6B, 7F, 9V, 14, and 23F conjugated to protein D, 3 µg of serotype 4 conjugated to protein D, 3 µg of serotype 18C conjugated to tetanus toxoid and 3 µg of serotype 19F conjugated to diphtheria toxoid.
Other Names:
  • PHiD-CV
  • PHiD-CV10

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   9 Months to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Australian Indigenous infant who was a participant in PREV-IX_COMBO trial of primary course pneumococcal conjugate vaccines, age at least 2 months post final dose of primary course. Signed informed consent.

Exclusion Criteria:

  • adverse reaction to Prevenar13 or Synflorix
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735084

Locations
Australia, Northern Territory
Menzies School of Health Research
Darwin, Northern Territory, Australia, 0810
Sponsors and Collaborators
Menzies School of Health Research
National Health and Medical Research Council, Australia
Investigators
Principal Investigator: Amanda J Leach, PhD Menzies School of Health Research
  More Information

Publications:

Responsible Party: Menzies School of Health Research
ClinicalTrials.gov Identifier: NCT01735084     History of Changes
Other Study ID Numbers: 1046999
Study First Received: November 15, 2012
Last Updated: April 8, 2014
Health Authority: Australia: National Health and Medical Research Council
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Menzies School of Health Research:
randomized controlled trial
pneumococcal conjugate vaccines
booster dose
immunogenicity
nasopharyngeal carriage
Australian Indigenous
pediatric

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Otitis Media
Respiratory Tract Diseases
Otitis
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014